2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

Identification of preexisting adaptive immunity to Cas9 proteins in humans

(2019) Carsten T. Charlesworth et al.   NATURE MEDICINE

Comparison between a new multiplex electrochemiluminescence assay and the WHO reference enzyme-linked immunosorbent assay to measure serum antibodies against pneumococcal serotype-specific polysaccharides

(2019) Muriel Feyssaguet et al.   VACCINE

Immunogenicity testing of therapeutic antibodies in ocular fluids after intravitreal injection

(2018) Uwe Wessels et al.   Bioanalysis

Excessive outlier removal may result in cut points that are not suitable for immunogenicity assessments

(2018) Robert J. Kubiak et al.   JOURNAL OF IMMUNOLOGICAL METHODS

2018 White Paper on Recent Issues in Bioanalysis: ‘A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)’ (Part 1 – small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis)

(2018) Jan Welink et al.   Bioanalysis

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 – LBA/cell-based assays: immunogenicity, biomarkers and PK assays)

(2018) Lauren Stevenson et al.   Bioanalysis

2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 – PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies’ inputs on bioanalysis, biomarkers and immunogenicity)

(2018) Hendrik Neubert et al.   Bioanalysis

Unraveling the Complex Story of Immune Responses to AAV Vectors Trial After Trial

(2017) Céline Vandamme et al.   HUMAN GENE THERAPY

Novel drug and soluble target tolerant antidrug antibody assay for therapeutic antibodies bearing the P329G mutation

(2017) Uwe Wessels et al.   Bioanalysis

2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 – LBA: immunogenicity, biomarkers and PK assays)

(2017) Shalini Gupta et al.   Bioanalysis

The Decennial Index of the White Papers in Bioanalysis: ‘A Decade of Recommendations (2007–2016)’

(2017) Wei Garofolo et al.   Bioanalysis

2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies’ inputs)

(2017) Hendrik Neubert et al.   Bioanalysis

2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines ‘Scientific’? (Part 1 – LCMS: small molecules, peptides and small molecule biomarkers)

(2017) Jan Welink et al.   Bioanalysis

Pre-existing Antibody: Biotherapeutic Modality-Based Review

(2016) Boris Gorovits et al.   AAPS Journal

On the Dependency of Cellular Protein Levels on mRNA Abundance

(2016) Yansheng Liu et al.   CELL

Recommendations for the development and validation of flow cytometry-based receptor occupancy assays

(2016) Cherie L. Green et al.   CYTOMETRY PART B-CLINICAL CYTOMETRY

Role of receptor occupancy assays by flow cytometry in drug development

(2016) Jennifer J. Stewart et al.   CYTOMETRY PART B-CLINICAL CYTOMETRY

An immunoinhibition approach to overcome the impact of pre-existing antibodies on cut point establishment for immunogenicity assessment of moxetumomab pasudotox

(2016) Amy K. Schneider et al.   JOURNAL OF IMMUNOLOGICAL METHODS

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity)

(2016) Susan Richards et al.   Bioanalysis

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 – small molecules, peptides and small molecule biomarkers by LCMS)

(2016) Eric Yang et al.   Bioanalysis

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 – Hybrid LBA/LCMS and input from regulatory agencies)

(2016) An Song et al.   Bioanalysis

Storage Conditions of Conjugated Reagents Can Impact Results of Immunogenicity Assays

(2016) Robert J. Kubiak et al.   Journal of Immunology Research

The evolution of guidelines for the validation of flow cytometric methods

(2015) L. Du et al.   International Journal of Laboratory Hematology

Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development

(2015) Lynette Brown et al.   JOURNAL OF IMMUNOLOGICAL METHODS

A breakthrough novel method to resolve the drug and target interference problem in immunogenicity assays

(2015) Jad Zoghbi et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Effects of blood processing and sample storage on the stability of biotherapeutics and anti-drug antibodies

(2015) Matthew Andisik et al.   Bioanalysis

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 – hybrid LBA/LCMS and input from regulatory agencies)

(2015) Brad Ackermann et al.   Bioanalysis

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 – small molecules by LCMS)

(2015) Jan Welink et al.   Bioanalysis

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 – LBA, biomarkers and immunogenicity)

(2015) Lakshmi Amaravadi et al.   Bioanalysis

Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team

(2014) Lindsay E. King et al.   AAPS Journal

Statistical Evaluation of Several Methods for Cut-Point Determination of Immunogenicity Screening Assay

(2014) Meiyu Shen et al.   Journal of Biopharmaceutical Statistics

Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics

(2014) Boris Gorovits et al.   JOURNAL OF IMMUNOLOGICAL METHODS

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1 – small molecules by LCMS)

(2014) Eric Fluhler et al.   Bioanalysis

Stability of anti-immunotherapeutic antibodies in frozen human serum samples

(2014) Lydia Michaut et al.   Bioanalysis

EBF recommendation for stability testing of anti-drug antibodies; lessons learned from anti-vaccine antibody stability studies

(2014) Susanne Pihl et al.   Bioanalysis

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 – hybrid LBA/LCMS, ELN & regulatory agencies’ input)

(2014) Dawn Dufield et al.   Bioanalysis

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)

(2014) Lauren Stevenson et al.   Bioanalysis

Parallelism: considerations for the development, validation and implementation of PK and biomarker ligand-binding assays

(2014) Lauren F Stevenson et al.   Bioanalysis

Validation of cell-based fluorescence assays: Practice guidelines from the ICSH and ICCS - part V - assay performance criteria

(2013) Brent Wood et al.   CYTOMETRY PART B-CLINICAL CYTOMETRY

2013 White Paper on recent issues in bioanalysis: ‘hybrid’ – the best of LBA and LCMS

(2013) Lauren Stevenson et al.   Bioanalysis

Ligand Binding Assays in the 21st Century Laboratory: Recommendations for Characterization and Supply of Critical Reagents

(2012) Denise M. O’Hara et al.   AAPS Journal

Correlation of screening and confirmatory results in tiered immunogenicity testing by solution-phase bridging assays

(2012) Robert J. Kubiak et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines

(2012) Binodh DeSilva et al.   Bioanalysis

Interactions of formulation excipients with proteins in solution and in the dried state

(2011) Satoshi Ohtake et al.   ADVANCED DRUG DELIVERY REVIEWS

Quality requirements for critical assay reagents used in bioanalysis of therapeutic proteins: what bioanalysts should know about their reagents

(2011) Roland F Staack et al.   Bioanalysis

2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections

(2011) Fabio Garofolo et al.   Bioanalysis

Recommendations for the validation of flow cytometric testing during drug development: I instrumentation

(2010) Cherie L. Green et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Recommendations for the validation of flow cytometric testing during drug development: II assays

(2010) Denise M. O'Hara et al.   JOURNAL OF IMMUNOLOGICAL METHODS

2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance

(2010) Natasha Savoie et al.   Bioanalysis

The MIQE Guidelines: Minimum Information for Publication of Quantitative Real-Time PCR Experiments

(2009) S. A. Bustin et al.   CLINICAL CHEMISTRY

The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice bioanalysis

(2009) Natasha Savoie et al.   Bioanalysis

2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop

(2009) Natasha Savoie et al.   Bioanalysis